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Alkylating agent
Selumetinib + Cisplatin/Gemcitabine for Biliary Cancer
Phase 2
Waitlist Available
Led By Jennifer Knox, M.D.
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Unresectable, recurrent or metastatic, measurable biliary tract cancer or gall bladder cancer
Performance status 0, 1, or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will compare two schedules of selumetinib given with cisplatin and gemcitabine to cisplatin and gemcitabine alone.
Who is the study for?
Adults with advanced biliary or gallbladder cancer who haven't had systemic therapy can join this trial. They should be in a condition to perform daily activities (performance status 0, 1, or 2), have an expected lifespan of over three months, and their blood counts and organ functions must meet certain standards. Pregnant women, those with recent other cancers, severe heart or eye conditions, uncontrolled diseases like hepatitis or HIV are excluded.Check my eligibility
What is being tested?
This phase II study is testing the effectiveness of Selumetinib combined with Cisplatin/Gemcitabine versus just Cisplatin/Gemcitabine in patients. Selumetinib is taken orally and targets cell growth regulation while both Cisplatin and Gemcitabine are given intravenously to damage DNA in tumor cells.See study design
What are the potential side effects?
Selumetinib may cause rash, fatigue, nausea, diarrhea; vision changes are also possible due to its effect on cell growth pathways. Cisplatin and Gemcitabine can lead to side effects such as kidney damage, hearing problems for the former; low blood counts causing infection risk for both.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer in the bile duct or gallbladder cannot be removed by surgery and has spread.
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I can take care of myself but might not be able to do heavy physical work.
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I have not had any drug treatments that work throughout my body.
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I do not have any ongoing infections that aren't under control.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Neoplasms
Secondary outcome measures
Disease
Overall survival in months
Percentage of patients without progressive disease
+3 moreSide effects data
From 2012 Phase 2 trial • 37 Patients • NCT0108521475%
Diarrhea
50%
Fatigue
47%
Anemia
47%
Rash acneiform
44%
Hypoalbuminemia
44%
Edema, limbs
39%
Aspartate aminotransferase increased
33%
Neutrophil count decreased
33%
White blood cell decreased
31%
Nausea
31%
Vomiting
28%
Platelet count decreased
25%
CPK increased
25%
Hypomagnesemia
22%
Hypertension
19%
Hypophosphatemia
19%
Hypocalcemia
19%
Hyponatremia
19%
Edema, face
17%
Dry skin
17%
Alanine aminotransferase increased
14%
Skin and subcutaneous tissue disorders - Other
14%
Hypokalemia
14%
Creatinine increased
14%
Back pain
14%
Dyspnea
14%
Lymphocyte count decreased
11%
Pain
11%
Fever
11%
Localized edema
11%
Peripheral sensory neuropathy
11%
Hyperkalemia
11%
Dizziness
11%
Abdominal pain
8%
Acute kidney injury
8%
Hypoglycemia
8%
Anorexia
8%
Death, NOS
8%
Periorbital edema
8%
Skin hypopigmentation
8%
Pain in extremity
8%
Cough
8%
Insomnia
8%
Alkaline phosphatase increased
8%
Dry mouth
8%
Sepsis
6%
Renal and urinary disorders - Other
6%
Dehydration
6%
Musculoskeletal and connective tissue disorder - Other, Rhabdomyolysis
6%
Hypernatremia
6%
Blood and lymphatic system disorders - Other
6%
Hypercalcemia
6%
Metabolism and nutrition disorders - Other
6%
Chills
6%
Hypotension
6%
Myalgia
6%
Arthralgia
6%
Upper respiratory infection
6%
Headache
6%
Sinusitis
6%
Generalized muscle weakness
6%
Gastrointestinal disorders - Other
6%
Gastroesophageal reflux disease
3%
Confusion
3%
Vaginal inflammation
3%
Pruritus
3%
Febrile neutropenia
3%
Flu like symptoms
3%
Hepatic failure
3%
Skin infection
3%
Fall
3%
Fracture
3%
Skin and subcutaneous tissue disorders - Other, Angular cheilitis, unilateral
3%
Adult respiratory distress syndrome
3%
Renal and urinary disorders - Other, Acute renal failure
3%
INR increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
AZD6244 (Selumetinib) Treatment
Trial Design
3Treatment groups
Experimental Treatment
Group I: Arm C (Standard Care)Experimental Treatment2 Interventions
Cisplatin/gemcitabine, intravenously, on Days 1 and 8 of every 28 day cycle.
Group II: Arm B (Sequential Dosing)Experimental Treatment3 Interventions
Run-In: Selumetinib, orally, BID for 5 days (Day -7 to Day -3) with 2 days washout
On treatment: Selumetinib, orally, BID from Day 1-5 and 8-19 of every 28 day cycle.
Cisplatin/gemcitabine, intravenously, on Days 1 and 8 of every 28 day cycle.
Group III: Arm A (Continuous Dosing)Experimental Treatment3 Interventions
Run-In: Selumetinib, orally, BID for 7 days (Day -7 to Day -1)
On treatment: Selumetinib, orally, BID from Day 1-21 of every 28 day cycle. Cisplatin/gemcitabine, intravenously, on Days 1 and 8 of every 28 day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
FDA approved
Selumetinib
FDA approved
Cisplatin
FDA approved
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,483 Previous Clinical Trials
486,360 Total Patients Enrolled
Jennifer Knox, M.D.Principal InvestigatorPrincess Margaret Cancer Centre
2 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had chemotherapy or a MEK inhibitor for cancer that couldn't be surgically removed.My condition worsened within 6 months after my last cancer treatment.I have never taken MEK, RAS, or RAF inhibitors and am not allergic to study drugs.I have serious heart problems.I do not have any ongoing infections, bleeding disorders, or a history of kidney transplant.I have been diagnosed with ampullary carcinoma.I have had problems with my eyes in the past.My cancer in the bile duct or gallbladder cannot be removed by surgery and has spread.I can take care of myself but might not be able to do heavy physical work.I am currently receiving treatment aimed at curing my condition.I have not had any drug treatments that work throughout my body.I do not have any ongoing infections that aren't under control.I am 18 years old or older.My condition worsened within 3 to 6 months after treatment.I have another cancer that might affect how my treatment response is measured.My blood, liver, and kidney functions are within normal ranges.I have not fully recovered from my last surgery.I am taking strong medication that affects liver enzymes but can proceed carefully.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (Sequential Dosing)
- Group 2: Arm C (Standard Care)
- Group 3: Arm A (Continuous Dosing)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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